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NCT Number: NCT06135870

Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)

The investigators are evaluating the role of senescent cells in uterine fibroids.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Rachel Mitchel

CONTACT

[email protected]

About this study

Uterine fibroids are prevalent tumors of uterus characterized by excessive fibrotic tissues. Using new cutting-edge computational methods, the investigators have found that small groups of senescent cells in fibroids work in concert with immune cells to produce soluble factors in fibroid tissues to create a feed-forward loop leading to fibrosis. This project seeks to unravel key cell-cell communication networks involving senescent and immune cells in fibroids to develop new treatments for uterine fibroids.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be women above the age of ≥18 - ≤55 years.
  • Women with suspected uterine fibroids.
  • Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.
  • Subject must be able to understand, read and speak English or Spanish and subsequently, be able to understand what she is consenting to in terms of procedures and use/disclosure of protected health information.

Exclusion criteria

  • Unwilling to sign the consent form or complete questionnaire.
  • Pregnancy.
  • Cancer of the uterus

Treatment and study plan

Primary outcomes

  1. Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples

    Time frame: 5 years

    Perform scRNASeq on human fibroids and control myometrium tissue and apply transfer learning algorithm for SnC identification and phenotyping to identify cell-cell communication patterns in fibroids versus control myometrial tissue using Domino to validate computationally predicted senescent cell types. The computationally predicted immune phenotypes will be validated with flow cytometry.

Secondary outcomes

  1. Validate the concentration senescence-associated secretory profile (SASP) in cell cultures of senescent cells in uterine fibroids

    Time frame: 5 years

    Quantify levels of transcripts and proteins in the fibroid senescence-associated secretory profile (SASP) using ELISA and western blotting techniques

  2. Rate of inhibition of cellular proliferation and ECM deposition by senolytics and senomorphics in fibroids

    Time frame: 5 years

    Examine the in-vitro effects of senotherapeutcis using leiomyoma culture models and in mouse models. Measured by inhibition of proliferation, induction of apoptosis, inhibition ECM deposition, decrease in SnCs (senolytics) and senescence-associated secretory profile SASPs (senomorphics).

Study contacts

Contact information is provided by the study sponsor or research team.

Bhuchitra Singh, MD, MPH, MBA

CONTACT

[email protected]

410-614-2000

James Segars, MD

CONTACT

[email protected]

410-614-2000

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Role of Senescent Cells in Uterine Fibroid Pathogenesis

Acronym: SOUL

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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